2/17 Taiwan Life Sciences Biweekly Newsletter
2025-02-17 |
| Taiwan Life Sciences Biweekly |
| Lotus Announces TFDA Approval for Adcirca for PAH Treatment 12 February, 2025 Lotus Pharmaceutical Co., Ltd. (TW: 1795), a leading global pharmaceutical company, announces that Adcirca (tadalafil) has been approved by the Taiwan Food and Drug Administration (TFDA) for treating pulmonary arterial hypertension (PAH). PAH is a rare, progressive disease with no cure. The 2022 ESC/ERS Guidelines recommend tadalafil as the only Class I therapy in combination with endothelin receptor antagonists (ERAs) for first-line treatment. Previously, cardiologists in Taiwan relied on another PDE5 inhibitor with weaker evidence in combination therapy. More... (in Chinese) |
| Foresee Pharmaceuticals reports new drug progress 12 February, 2025 Foresee Pharmaceuticals (TW: 6576) announced positive developments in its new drug pipeline. Following the potential US FDA approval of its three-month formulation of CAMCEVI for prostate cancer in August this year, the company has now submitted an application for market approval of its six-month extended-release formulation to China's National Medical Products Administration (NMPA). The review process is estimated to take approximately 18 to 24 months, with approval expected as early as the end of next year. Foresee stated that its Chinese licensing partner, Changchun Jinsai Pharmaceutical, has officially submitted the injectable suspension form for approval in China, primarily intended for the treatment of adult advanced prostate cancer. According to global cancer database GLOBOCAN, prostate cancer is the second most common cancer among men worldwide. In 2022, 14.2 percent of the 10 million new cancer cases in men were prostate cancer, with China accounting for approximately 9 percent of cases, equating to 134,000 new cases annually. More... (in Chinese) |
| EirGenix partners with Australian pharmaceutical firm to develop new drug 11 February, 2025 EirGenix (TW: 6589) announced that it had signed a partnership agreement with Australian pharmaceutical company Clarity Pharmaceuticals, Ltd. Under the agreement, EirGenix will initially supply the active pharmaceutical ingredient for its breast cancer biosimilar EG12014 (Trastuzumab Biosimilar) to Clarity for the development of its innovative radioimmunotherapy drug Cu-64/67 SAR-trastuzumab for breast cancer. The collaboration will focus on advancing the clinical development and subsequent market launch, with both parties planning to target the Australian and international markets. Additionally, once Clarity's Cu-64/67 SAR-trastuzumab completes key development phases and successfully enters the market, EirGenix will receive milestone payments and share in the product's post-launch sales royalties. More... (in Chinese) |
| January revenue for Mycenax and PharmaEssentia doubles YoY 10 February, 2025 Despite fewer working days due to the Lunar New Year holiday, over 14 biotech companies saw more than 10 percent year-over-year revenue growth in January, with Mycenax (TW: 4726) and PharmaEssentia (TW: 6446) leading the way with revenue doubling compared to the previous year. Additionally, Syn-Tech Chem & Pharm (TW: 1777) and SCI Pharmtech (TW: 4119) also posted double-digit revenue growth in January. More... (in Chinese) |
| New cancer signaling mechanism found 10 February, 2025 Researchers from National Chung Cheng University (CCU) and National Cheng Kung University (NCKU) have identified a novel signaling mechanism in pancreatic cancer patients, knowledge of which might help improve survival rates for the deadly disease. The newly-discovered TIMP1-CD63 signaling mechanism causes Kirsten rat sarcoma viral oncogene homologue (KRAS)-mutated cells found in about 90 percent of pancreatic cancer patients to evade destruction by the immune system, the CCU and NCKU said last week. The researchers found that a gene deficiency known as dual specificity phosphatase-2 (DUSP2) helps KRAS-mutated cells continue growing. More... |
| Shine-On BioMedical applies for US clinical trial of exosome-based cancer drug SOB100 10 February, 2025 On February 10, Shine-On BioMedical (TW: 6926) announced that it had submitted an Investigational New Drug (IND) application to the US FDA for its exosome-based cancer drug carrier, SOB100, which targets HLA-G cancer cells. This marks the first case of a Taiwanese biotech company developing an exosome-based novel drug. More... (in Chinese) |
| NaviFUS reports progress competing in international markets 8 February, 2025 NaviFUS Corporation (TW: 6872) is set to be listed on March 7 and will hold a pre-listing performance presentation on the same day. The company stated that the global competition for brain disease treatments is intensifying, but that the company's NaviFUS Navigated Focused Ultrasound System for treating recurrent glioblastoma (rGBM) has entered Phase III clinical trials and is competing internationally against Israel s Insightec and France s Carthera, aiming for regulatory approval by 2026 or 2027. More... (in Chinese) |
| Caliway reports clinical progress for injectable drug for localized fat reduction 6 February, 2025 Caliway Biopharmaceuticals (TW: 6919) announced the final results of its Phase IIb clinical trial for CBL-514, a novel small-molecule injectable drug developed under the 505(b)(1) pathway for localized fat reduction. The latest data from the CBL-0205 clinical trial demonstrated that the drug met its primary efficacy endpoint along with multiple secondary efficacy endpoints. Caliway reported that the trial was conducted in the US and Canada, enrolling a total of 173 participants who were assessed with the Abdominal Fat Rating Scale (AFRS) as having moderate (Grade 3) or severe (Grade 4) abdominal fat accumulation. More... (in Chinese) |
| With new leukemia drug success, PharmaEssentia's January revenue hits NT$1.06 billion, doubling YoY Press release 6 February, 2025 PharmaEssentia (TW: 6446) reported NT$1.06 billion in revenue for January, marking a 107.87 percent year-on-year increase. The growth was driven primarily by the strong sales of its rare blood cancer drug, Ropeginterferon alfa-2b (Ropeg, P1101), in the US and global markets, achieving over NT$1 billion in revenue for three consecutive months. European, US, and Canadian health authorities have announced a delay in the shipment of Pegasys, a competing drug to Ropeg, attracting attention in the pharmaceutical industry. In the UK alone, Pegasys is used by around 2,000 patients, and the National Health Service (NHS) has confirmed that it will subsidize Ropeg for patients during the Pegasys shortage. According to the European Medicines Agency (EMA), this shortage is expected to last until the second half of 2025, and Canada's drug shortage report website estimates that the shortage will persist until the end of the year. More... (in Chinese) |
| TaiwanBio Therapeutics' anti-rejection new drug approved for Phase II clinical trials Press release 5 February, 2025 TaiwanBio Therapeutics (TW: 6892) announced that its anti-rejection new drug TregCel (TRK-001), for the prevention of solid organ transplant rejection, has received approval from Taiwan's TFDA to proceed with Phase II clinical trials. TRK-001 has already been approved by the US FDA for Phase II clinical trials and has been granted approval to add Taiwan as a recruitment center. This makes TaiwanBio the first company in the country to simultaneously launch a multinational, multi-center regulatory T cell clinical trial in both the US and Taiwan. More... (in Chinese) |
| Andros Pharmaceuticals accelerates clinical trials for two new drugs 5 February, 2025 Andros Pharmaceuticals (TW: 6917) has started the year strongly, with the company's spray-type new drug APC101, used to alleviate postherpetic neuralgia associated with shingles, is preparing for a Phase III clinical trial application. Meanwhile, APC201, a foam-based new drug for treating osteoarthritis pain, will have complete Phase II data reports in the first half of this year. With the progress of clinical trials, the company is actively seeking international licensing and collaboration opportunities. More... (in Chinese) |
| [Taiwan's] China Medical University and Healthcare System Pioneers AI-Driven Drug Discovery and Allogeneic CAR-T Therapy: A Groundbreaking Leap in Cancer Treatment Press release 5 February, 2025 [Taiwan's] China Medical University (CMU) and Healthcare System unveiled groundbreaking advancements in AI-driven drug discovery and cancer therapy at the latest 8th Healthcare Expo. These achievements cement CMU and Healthcare System's position as a global leader in healthcare innovation, setting new benchmarks for the biomedical industry. More... |
| PharmaEngine's pancreatic cancer drug sales meet targets, receives over NT$1.6 Billion in licensing fees 5 February, 2025 Biopharmaceutical company PharmaEngine (TW: 4162) announced that its pancreatic cancer drug ONIVYDE has reached the second-phase sales milestone, with net sales triggering a US$50 million milestone payment, equivalent to over NT$1.6 billion. Following the positive news, PharmaEngine's stock price surged and hit the daily limit, reaching NT$113 in early trading. More... (in Chinese) |
| Ever Supreme Bio Technology, EverFortune.ai start the year with good news 4 February, 2025 Ever Supreme Bio Technology (TW: 6712) reported January revenue of NT$59.51 million, setting a new record for the same period, marking an 11.23 percent year-on-year increase. The company reported that its contract development and manufacturing (CDMO) orders have extended into the fourth quarter, and the number of cooperative hospitals and cell therapy projects is continuously expanding. The company is optimistic about its 2025 operations, with the potential to achieve new highs. EverFortune.ai (TW: 6841) benefited from last year's revenue of NT$345 million, a new record. The company plans to distribute a cash dividend of NT$1 per share to reward shareholders. With increasing medical device licenses both domestically and internationally and the launch of various products, the company is optimistic about its 2025 operations, with the market estimating a revenue growth rate starting at 40 percent. More... (in Chinese) |
| Oneness Biotech, Panion & BF Biotech advance new drugs in China 3 February, 2025 Taiwan's biotech sector is set for continued momentum in 2025. Oneness Biotech's (TW: 4743) diabetic foot ulcer treatment, FB825 (Suglat), has launched in China, while Panion & BF Biotech's (TW: 1760) Picoplatin is expected to receive market approval from China s National Medical Products Administration (NMPA). |
| Bora Pharmaceuticals expands global manufacturing to adapt to new US tariff policies 3 February, 2025 Bora Pharmaceuticals (TW: 6472) announced that, as Taiwan's largest pharmaceutical exporter, it is fully prepared for the latest US tariff policies. With its globally diversified production capacity and last year's acquisition in the US enhancing local supply capabilities, the company has the flexibility to adapt to policy changes, significantly minimizing the impact. The company has established advanced manufacturing, packaging, and logistics facilities across Asia and North America, including a production site in Mississauga, Ontario, Canada. Through strategic capacity and supply chain management, Bora ensures a stable pharmaceutical supply to over 100 global markets, despite evolving geopolitical and trade conditions. More... (in Chinese) |
| ========================================= |
| Taiwan Bio Industry Organization (Taiwan BIO) Contact: Daisy Tsai Tel: +886 2 27836028 ext 14 FAX : +886 2 27836027 Mobile: +886 933-139647 | Line ID : daisy222 Email: daisy@taiwanbio.org.tw BIO Asia-Taiwan 2025 (23-27 July, 2025) ========================================= Taiwan Bio Industry Organization (TBIO) Room C229, Bldg. C, No.99, Ln. 130, Sec. 1, Academia Rd., Nangang Dist., Taipei, Taiwan (11571) ========================================= |